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Immunosuppressant

Belatacept Injection for Kidney Transplant

Phase 1 & 2

Recruiting

Led By Piotr Witkowski, MD PhD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ebstein Barr Virus (EBV) Immunoglobulins (IgG) seropositive

No active systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will test whether belatacept, when given with a proteasome inhibitor, can help highly HLA sensitized kidney transplant candidates find an acceptable donor.

Who is the study for?

This trial is for highly sensitized kidney transplant candidates who are EBV IgG positive, have no active infections or allergies to the drugs being tested, and are not pregnant. They must be vaccinated against COVID-19 and hepatitis B, listed for a transplant at University of Chicago, and agree to use two contraception methods post-treatment.Check my eligibility

What is being tested?

The study tests if belatacept combined with a proteasome inhibitor can safely help find suitable donors for patients with high HLA sensitivity needing a kidney transplant. It aims to increase the chances of successful transplantation.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to belatacept or issues associated with proteasome inhibitors like Bortezomib. Specific side effects aren't listed but could align with known profiles of these medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have antibodies against the Epstein-Barr Virus.

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I do not have any ongoing infections.

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I have been fully vaccinated against COVID-19 for at least 2 weeks.

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I haven't had any cancer except for skin cancer in the last 2 years.

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I agree to use two forms of birth control for 3 months after my last Bortezomib dose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Likelihood of finding a donor to whom the study participant does not have strong anti-donor HLA specific antibodies (DSA).

Secondary outcome measures

Death

Episodes of Antibody Mediated Rejection (AMR) and Acute Cellular Rejection (ACR)

Post-transplant lymphoproliferative disorder

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients treated with belatacept and proteasome inhibitorExperimental Treatment1 Intervention

Highly sensitized patients will be treated with belatacept and proteasome inhibitor and monitored for decreasing calculated Panel of Reactive Antibodies (cPRA) and suitable kidney donor base don negative crossmatch

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,003 Previous Clinical Trials

819,744 Total Patients Enrolled

Piotr Witkowski, MD PhDPrincipal InvestigatorUniversity of Chicago

Media Library

Belatacept (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT05345717 — Phase 1 & 2

Renal Disease Research Study Groups: Patients treated with belatacept and proteasome inhibitor

Renal Disease Clinical Trial 2023: Belatacept Highlights & Side Effects. Trial Name: NCT05345717 — Phase 1 & 2

Belatacept (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05345717 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being enrolled in this particular clinical trial?

"According to the latest update on clinicaltrials.gov, this research is actively recruiting subjects. The trial was initially advertised on May 1st, 2020 and has since been updated 13 days ago."

Answered by AI

How many people are eligible to participate in this clinical trial?

"That is correct. The listing on clinicaltrials.gov says that the trial is still open and looking for candidates. This study was first posted on May 1st, 2022 and received its most recent update on May 13th, 2022. So far, only 5 people have been recruited from a single site."

Answered by AI

What are the inclusionary criteria for this trial?

"This study has 5 open slots for participants that fit the following description: experiencing chronic kidney failure, aged 18-60, and vaccinated against hepatitis b with positive HBsAb levels. Additionally, candidates must be EBV IgG seropositive and actively listed for transplant at the University of Chicago's Transplant Institute. There can be no active systemic infection, malignancy in the past 2 years (with exception of non-melanomatous skin cancer), or allergies to belatacept or proteasome inhibitors. Finally, this study is only for female patients who agree to use 2 forms of contraception for 3 months after"

Answered by AI

Are elderly patients above the age of 75 eligible to participate in this clinical trial?

"This trial is only seeking patients that fall in the age bracket of 18 to 60 years old. Out of the 639 total trials, 63 are for minors and 639 are for senior citizens."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Novel Desensitization Kidney Transplantation

2022. "Novel Desensitization Kidney Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05345717.

All > Kidney Transplant